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FDA Approves Ustekinumab-stba for All Forms & Dosages as Its Reference Product

  |  Issue: August 2025  |  

References

  1. Celltrion announces U.S. FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients [news release]. Celltrion Inc. 2025 Jun 16.
  2. Biologics license application approval letter: Steqeyma (ustekinumab-stba). U.S. Food & Drug Administration. 2024 Dec 17.
  3. Biologics license application approval letter: Stelara (ustekinumab). U.S. Food & Drug Administration. 2009 Sep 25.
  4. Highlights of subscribing information: Stelara (ustekinumab). U.S. Food & Drug Administration. 2024 Nov.
  5. Purple Book: Database of licensed biologic products. Ustekinumab. U.S. Food & Drug Administration. 2025.

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